Stivarga News

Stivarga Q&A

STIVARGA SUMMARY

Regorafenib is a small molecule inhibitor of multiple membrane-bound and intracellular kinases involved in normal cellular functions and in pathologic processes such as oncogenesis, tumor angiogenesis, and maintenance of the tumor microenvironment.

StivargaŽ is indicated for the treatment of patients with metastatic colorectal cancer (CRC) who have been previously treated with fluoropyrimidine-, oxaliplatin- and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if KRAS wild type, an anti-EGFR therapy.

Approximately 530 patients who meet the entry criteria will be randomly assigned in a 2: 1
ratio to regorafenib or placebo (1/3 chance to receive placebo).

Primary endpoint of the study is overall survival.

Second-line FOLFOX With or Without Regorafenib in mCRC Patients Failed to First-line Irinotecan Plus Fluoropyrimidines [Not yet recruiting]
Regorafenib has been proved to improved survival in patients with metastatic colorectal
cancer who have been failed to all of known standard chemotherapy (The CORRECT study). The
phase Ib study of regorafenib plus FOLFOX or FOLFIRI was performed and the dose of
regorafenib was fixed; 160 mg/day on days 4 to 10 (7 days per cycle when combined with
FOLFOX or FOLFIRI). Regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who
progressed after first-line irinotecan-based chemotherapy has not been studied yet, and
because there have been unmet needs for the discovery of valid targeted agent combination
for the second-line FOLFOX as above reasons, the investigators planned this study of
regorafenib plus FOLFOX as second-line chemotherapy in mCRC patients who progressed after
first-line irinotecan-based chemotherapy.

Regorafenib is an oral (i. e. taken by mouth) multi-targeted kinase inhibitor. A kinase
inhibitor targets certain key proteins that are essential for the survival of the cancer
cell. By specifically targeting these proteins, regorafenib may stop cancer growth. The
growth of the tumor may be decreased by preventing these specific proteins from functioning.